MONDAY, July 11, 2016 (HealthDay News) -- The once-daily acne treatment Differin Gel 0.1% (adapalene) has been approved for over-the counter use among people 12 and older, the U.S. Food and Drug Administration said.
It's the first among a class of drugs called retinoids to be made available over the counter to treat acne. The drug's active ingredient is the first new OTC acne treatment approved since the 1980s, the FDA said in a news release.
Differin Gel 0.1% was first approved in 1996 as a prescription drug.
Acne affects some 50 million people in the United States, mostly teens and young adults, the FDA said. Clusters of pimples most often form on the face, neck, back, chest and shoulders.
The agency warned that women who are pregnant, planning to become pregnant or breast feeding should get their doctor's approval before using the product. While no specific issues with pregnant or breast-feeding women using Differin Gel have been identified, some retinoid drugs have been shown to cause birth defects, the FDA said.
Differin Gel 0.1% is distributed by Galderma Laboratories, based in Fort Worth, Tex.
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